It is indefensible that Health Canada has failed to register the opioid Tramadol under the Controlled Drugs and Substances Act, a drug-safety researcher says, noting the department explored making such a move in 2007, but backtracked.
Dr. David Juurlink, based at the University of Toronto, says Health Canada's inaction has helped to fuel perception that Tramadol is somehow safer than other opioids – powerful painkillers at the root of a national public health crisis.
Health Minister Jane Philpott and Public Safety Minister Ralph Goodale are currently in the midst of pushing legislation to combat opioid-related deaths across the country.
Tramadol – first marketed in Canada in 2005 and referred to as an 'opioid analgesic' in the product's scientific description – is a prescription-only drug, but Juurlink said it should also be listed as a controlled substance to help clinicians realize it is no different than drugs such as codeine. He said the U.S. has listed it.
"The classification (by Health Canada), as it currently exists, misleads doctors and other health professionals and possibly even patients as to the drug's safety and abuse liability," Juurlink said.
Rob, who asked The Canadian Press to withhold his real name for medical privacy reasons, is a Toronto-based financial executive who stumbled into a dependence on Tramadol after being prescribed the pill for shoulder pain in December 2015.
He said he discussed options with his doctor but opted to avoid Percocet – another powerful painkiller.
"Really, the story was this surgeon ... who sort of gave it to me, not really understanding or explaining anything," he said. "If the doctor would have said it acts in a similar way to Percocet, I never would have done it."
Rob is now trying to wean himself off Tramadol, but he has trouble sleeping when he reduces the dose.
"I don't want to be on drugs I don't have to be on," he said. "If I am taking it for pain, that is one thing, OK, I get it. But ... to take it for addiction? I don't smoke; I don't drink ... I'm an accidental addict."
For its part, Health Canada said it will continue to monitor Tramadol and "will schedule it under the Controlled Drugs and Substances Act if evidence indicates it is necessary."
Tramadol was considered by the World Health Organization's expert committee on drug dependence, the department said in a statement, noting it did not recommend its control internationally.
However, a Canada Gazette posting from July 2007 suggests the department was on the verge of listing it under the act, saying the move would benefit Canadians.
The Gazette is considered the government's newspaper and one of the ways to access information about laws and regulations.
"The increased control of Tramadol will serve to minimize its diversion, and the health risks associated with its illicit use," the entry said.
It noted the magnitude of the risk of abuse and dependence linked to Tramadol had not been definitively characterized in Canada, but it said clinical and non-clinical studies showed the drug can cause dependence in a similar way to other opioids, including oxycodone and morphine.
The listing also noted manufacturers of Tramadol voiced concerns regarding the proposal to schedule it under the Controlled Drug Substances Act, noting meetings had been held with both companies to explain the rationale.
"This option will ensure that practitioners and pharmacists are aware of the abuse potential of Tramadol when prescribing, dispensing, or storing it in order to prevent non-medical and illicit use and diversion of the substance," it said.
Juurlink believes lobbying contributed to the department's decision not to list it.
"It seems to me Health Canada is trying to justify a scientifically irrational position," he said.